Daratumumab or active observation for asymptomatic biochemical relapse in patients with multiple myeloma
The progression pattern of multiple myeloma is heterogeneous and often characterised by asymptomatic biochemical progression preceding the onset of organ-related symptoms. It is unknown whether pre-emptive treatment of biochemical progression can affect long-term outcomes. The PREDATOR-BR trial is a randomised, multicentre study that enrolled 92 patients who met criteria for biochemical progression but not the criteria for significant paraprotein relapse (SPR). The participants were assigned to either daratumumab monotherapy or observation. The primary end-point was event-free survival (EFS), defined as the time until clinical relapse, SPR or death from any cause. At the prespecified interim analysis with a median follow-up time of 16.7 months, the median EFS was 28.9 months with daratumumab and 4.0 months in the observation arm (hazard ratio [HR], 0.25; 95% confidence interval [CI], 0.14-0.43). The response rate was 61.0% in the treatment arm and 6.8% in the observation arm (p < 0.0001). The 24-month overall survival was 100% in the treatment group and 70.5% in the observation group (HR, 0.04; 95% CI, 0.00-0.34). Treatment was associated with manageable safety and no deterioration in quality of life. These results suggest that early treatment initiation during asymptomatic biochemical relapse of multiple myeloma may delay clinical relapse and prolong patient survival.
Authors
- Jan Maciej Zaucha (ORCID: https://orcid.org/0000-0002-0986-8936)
- Dominik Dytfeld (ORCID: https://orcid.org/0000-0003-0855-6591)
- Agnieszka Końska (ORCID: https://orcid.org/0009-0009-4077-7555)
- Anna Kopińska (ORCID: https://orcid.org/0000-0002-6821-7033)
- Tadeusz Kubicki (ORCID: https://orcid.org/0000-0001-7588-1453)
- Bartosz Puła (ORCID: https://orcid.org/0000-0003-0116-5002)
- K. Giannopoulos
- Grzegorz Helbig (ORCID: https://orcid.org/0000-0003-3703-1268)
- Agata Tyczyńska (ORCID: https://orcid.org/0000-0002-2067-2715)
- Magdalena Dutka (ORCID: https://orcid.org/0000-0001-8112-3974)
- Kamil Wiśniewski (ORCID: https://orcid.org/0000-0003-4164-9343)
- Marta Morawska (ORCID: https://orcid.org/0000-0001-6836-2903)
- K. Jamroziak
- Agnieszka Szeremet
- J Walewski
- Tomasz Górecki
- Tomasz Wróbel
- Jarosław Czyż
- Agnieszka Druzd‐Sitek
- Dorota Kruk‐Kwapisz
- Magdalena Olszewska‐Szopa
- Lidia Gil
Institutions
- Poznan University of Medical Sciences (PL)
- Medical University of Lublin (PL)
- Medical University of Silesia (PL)
- Medical University of Warsaw (PL)
- Nicolaus Copernicus University (PL)
- Institute of Haematology and Blood Transfusion (CZ)
- Górnośląskie Centrum Medyczne (PL)
- Copernicus Memorial Hospital (PL)
- National Institute of Oncology (HU)
- Cellular Therapeutics (United Kingdom) (GB)
- The Maria Sklodowska-Curie National Research Institute of Oncology (PL)
- Adam Mickiewicz University in Poznań (PL)
- Gdańsk Medical University (PL)
Publication Details
- Journal
- British Journal of Haematology
- Published
- 2026-02-17
- DOI
- https://doi.org/10.1111/bjh.70373
- Citations
- 1
- Primary Topic
- Multiple Myeloma Research and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 35.41
Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Gilead Sciences
- Celgene
- Regeneron Pharmaceuticals
- TG Therapeutics
- BeiGene
- Seagen
- Servier
- MorphoSys
- Janssen Pharmaceuticals
- Cilag